What Medical Manufacturers Need to Know about Software Validation


Medical device, equipment and supplies manufacturers are, in many ways, defined by their software validation. Not only is software validation required by the FDA, it directly shapes the quality of a manufacturer’s products. In this blog, we will review what medical manufacturers need to know about software validation in order to be successful.

What is Software Validation?

The FDA guidance document General Principles of Software Validation defines software validation as, “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” This definition is somewhat technical, but the key takeaway is that software validation is the system for confirming that an overall product meets the needs of its users. It requires “objective evidence,” meaning that you must develop documented, empirical proof that you have built the right product.

Software validation should not be confused with software verification, which is quite similar. Software validation is about confirming that you are building the right product, while software verification is about confirming that method for building the product makes sense. Both are highly important for medical manufacturers and a trusted ERP consultant like Datix can assist you in understanding how to incorporate both into your systems. At Datix, we strive to understand the wholistic vision of each of our clients and every aspect of their organization to support their goals.

FDA Requirements for Software Validation

The two main FDA requirements for software validation are currently: 

  • Your products and processes must meet or exceed FDA’s standards for production and inventory management
  • You must document every step of the validation process

The FDA’s requirements mean that your software validation business processes must be fully thought out and recorded so that you can showcase compliance. Scrambling to assemble documentation before an inspection or audit is a recipe for disaster. Instead, look at our five steps for preparing a software validation system.

Please note: the FDA has been in the process of updating their existing software validation guidance for some time, so be sure to stay cognizant of new FDA releases for updates on this subject.  

Steps to Completing Software Validation

To develop software validation, we recommend the following steps:

  1. Create your software validation plan: Work with your team to develop a comprehensive software validation plan as part of your larger product development strategy. Make sure to describe each aspect of the software and its operational environment. In addition, include any assumptions and limitations of the project, your established test acceptance criteria, the validation procedures, and the responsibility breakdown of your validation team. This plan will be your team’s master document, but feel free to adjust it if you identify that further steps are needed later in the process. If your software validation plan evolves or if you don’t know how to get it started, you can gain support from a software consultant like Datix. Our team is skilled in helping medical manufacturers set up simple and effective business processes to get the most out of their software. With Datix, you are supported every step of the way.
  2. Determine your system requirements (SRS): Outline the conditions that need to be in place, including staff, facility, equipment, security and operating environment requirements. Conduct a risk analysis to identify gaps in your functional requirements, if necessary.
  3. Create a validation protocol and test specifications: Map out what you expect the software to do, and develop a test plan, and test cases to identify potential errors by re-creating common user scenarios.
  4. Conduct and document tests: Execute your tests and document all successes, errors, and failures.
  5. Establish procedures and write your final report: Review your testing results to establish and revise procedures for using the software. Make sure this final report is seen and edited by key members of your team before it is approved. Don’t forget to add information on support, training, security backup, and software recovery. 

Wrap Up

Software validation requires a lot of planning, but it is possible to create a well-defined system to ensure that your products increase the quality of life for your customers. At Datix, our experts understand the importance of software validation for medical device, equipment and supplies manufacturers. We dedicate ourselves to analyzing each of our clients so that we can develop the best software solutions for you. 

Learn more about Datix’s Medical Manufacturing Solutions

About Datix

For medical manufacturers, Datix is the ERP consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.

Learn More About Our Mission to Our Clients  

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